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Analytical Method Development and Validation of Teneligliptin by using RP HPLC with ICH Guidelines

Analytical Method Development and Validation of Teneligliptin by using RP HPLC with ICH Guidelines

Teneligliptin is drug used against type 2 diabetes mellitus and it is also a member of class of anti diabetic drugs known as dipeptidyl peptidase 4 inhibitors or gliptins . A simple, sensitive and accurate RP HPLC method has been developed for the determination of Teneligliptin in bulk formulation. The max of the Teneligliptin was found to be 246 nm in Methanol Phosphate buffer pH 3 70 30 v v . The method shows high sensitivity with linearity 10 to 50 u00b5-g ml regression equation y = 54647x 74133 r2 = 0.9968 . The various parameters according to ICH guidelines are followed for validating and testing of this method. The Detection limit and quantitation limit were found to be 0.109 u00b5-g ml 1 and 0.3305 u00b5-g ml1 in Methanol Phosphate buffer pH 3 70 30 v v respectively. The purity of tablet formulation was found to be 99.57 . The results demonstrated that the procedure is accurate, specific and reproducible RSD 2 , and also being simple, cheap and less time consuming and appropriate for the determination of Teneligliptin in bulk and pharmaceutical formulation. Dr. Pradnya Lokhande "Analytical Method Development and Validation of Teneligliptin by using RP-HPLC with ICH Guidelines" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-3 , April 2019, URL: https://www.ijtsrd.com/papers/ijtsrd21735.pdf Paper URL: https://www.ijtsrd.com/chemistry/chromatography/21735/analytical-method-development-and-validation-of-teneligliptin-by-using-rp-hplc-with-ich-guidelines/dr-pradnya-lokhande

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Analytical Methods Development and Validation of Naproxen and Sumatriptan by RP HPLC

Analytical Methods Development and Validation of Naproxen and Sumatriptan by RP HPLC

Aim and objective A simple, pru00e9:cised, accurate method was developed for the estimation of Crizotinib by RP HPLC technique. Chromatographic conditions used are stationary phase BDS 250x4.6 mm, 5u00b5-. Mobile phase buffer Methodology Acetonitrile in the ratio of 60 40 and flow rate was maintained at1ml min, detection wave length was 267 nm, column temperature was set to 30o C and diluents was methanol water System suitability parameters were studied by injecting the standard five times and results were well 50 50 , Results and Discussion Conditions were finalized as optimized method under acceptance criteria. Linearity study was carried out between 25 to 150 levels, r2 value was found to be as 0.999. Precision was found to be 1.26 for repeatability and 0.93 for intermediate precision. LOD and LOQ are 0.080 ug ml. By using above method assay of marketed formulation was carried out 100.24 was present. Prapulla Putta "Analytical Methods Development and Validation of Naproxen and Sumatriptan by RP HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-4 , June 2019, URL: https://www.ijtsrd.com/papers/ijtsrd23582.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/23582/analytical-methods-development-and-validation-of-naproxen-and-sumatriptan-by-rp-hplc/prapulla-putta

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